Study on the Effectiveness and Safety of AP707 with Lamotrigine and Amitriptyline for Patients with Chronic Central Neuropathic Pain

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What is this study about?

This clinical trial is focused on evaluating the effectiveness and safety of a treatment called AP707 for individuals experiencing chronic pain due to central neuropathy. Central neuropathy is a condition where nerve damage in the central nervous system causes persistent pain. The study aims to determine how well AP707 works as an additional treatment for managing this type of pain.

Participants in the study will receive either the AP707 treatment or a placebo, which looks like the treatment but does not contain the active ingredient. The study will last for a total of 52 weeks, during which participants will be monitored at various intervals to assess changes in their pain levels and overall well-being. The treatment is administered as a sublingual spray, meaning it is sprayed under the tongue for absorption.

Throughout the study, participants’ pain levels will be measured using a simple scale, and other aspects such as quality of life, sleep quality, and psychological well-being will also be evaluated. The goal is to see if AP707 can provide significant relief from chronic pain and improve the quality of life for those affected by central neuropathy.

1 beginning of the trial

Upon joining the clinical trial, you will be introduced to the study’s objectives and procedures. You will be asked to provide a signed and dated informed consent form, confirming your understanding and willingness to participate.

You will be assessed to ensure you meet the inclusion criteria, such as having chronic pain due to central neuropathy for at least three months and a pain intensity of 5 or more on a scale from 0 to 10.

2 baseline assessment

Before starting the treatment, a baseline assessment will be conducted. This includes completing questionnaires to evaluate your current pain levels, psychological distress, and quality of life.

The Numeric Rating Scale (NRS) will be used to measure your pain intensity, and other questionnaires like the Neuropathic Pain Symptom Inventory (NPSI) and Depression Anxiety Stress Scales Short Form (DASS-21) will be administered.

3 treatment phase 1

You will begin the first treatment phase, which lasts for 14 weeks. During this time, you will receive either the active treatment, AP707, or a placebo. The treatment is administered as a sublingual spray, which means it is sprayed under the tongue.

Your pain levels and other health indicators will be monitored regularly. You will be asked to report any changes in your condition and any side effects you experience.

4 evaluation at week 14

At the end of the first treatment phase, your pain levels will be reassessed using the NRS and other questionnaires. This evaluation will help determine the effectiveness of the treatment.

You will continue to the next phase of the trial based on the results of this assessment.

5 treatment phase 2

The second treatment phase lasts until week 26. You will continue receiving the same treatment as in the first phase, either AP707 or placebo.

Regular monitoring and assessments will continue, focusing on changes in pain levels and overall health.

6 evaluation at week 26

Another evaluation will be conducted at the end of the second treatment phase. Your pain levels and other health indicators will be reassessed.

The results will be compared to previous assessments to track any improvements or changes.

7 treatment phase 3

The third and final treatment phase extends to week 52. You will continue with the same treatment regimen.

Ongoing assessments will be conducted to monitor your condition and any side effects.

8 final evaluation at week 52

At the end of the trial, a comprehensive evaluation will be conducted. This includes reassessing your pain levels, psychological distress, and quality of life.

The data collected throughout the trial will be analyzed to determine the overall efficacy and tolerability of the treatment.

Who Can Join the Study?

Signed and dated informed consent form.
Patients with chronic pain due to central neuropathy for at least 3 months. Central neuropathy refers to nerve damage in the central nervous system, which includes the brain and spinal cord.
Female and male patients who are 18 years or older.
Patients with a life expectancy of more than 1 year.
Patients with optimized sCPT at the start of the study. sCPT refers to a specific treatment plan that has been adjusted to the best possible level.
Willingness to use reliable contraception during the study and for three months after the last dose of study medication.
Good command of the German language to understand questionnaires in German.
Current moderate to severe pain with a pain intensity of 5 or more on a Numeric Rating Scale (NRS), which is a scale from 0 to 10 used to measure pain levels.
Completed QUISS questionnaire with a score of 45 or less. The QUISS is a questionnaire used to assess certain symptoms.

Who Cannot Join the Study?

Patients who have a different type of pain that is not caused by central neuropathy cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population, meaning they might need special protection or care, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Medical University Of Vienna	Vienna	Austria
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany

Other Sites

Site Name	City	Country
Klinikum Wels-Grieskirchen GmbH	Wels	Austria
Noe LGA Gesundheit Region Mitte GmbH	Tulln An Der Donau	Austria
Algesiologikum MVZ GmbH	Munich	Germany
Ueberoertliche Berufsausuebungsgemeinschaft Schmerz Und Palliativzentrum Rhein Main GbR	Frankfurt	Germany
Schmerzzentrum Bocholt	Bocholt	Germany
Saarland University Hospital	Homburg	Germany
Katholisches Klinikum Bochum gGmbH	Bochum	Germany
Schmerzzentrum Geldern	Geldern	Germany
Lqsbkvsdovsmmvcmyufpgydhsksqgcxfacjalfmjjhu Kohjm	Klagenfurt am Wörthersee	Austria
Udceeabopaxrllezjtjob Tcmzuqljy Aof	Tuebingen	Germany
Ctdrlpg Ulkkbvkdcmkpmjvyrdun Bybqif Krp	Berlin	Germany
Kvyxfy Ufcdkbsulqlqjcbsbdjsd Gulk	Linz	Austria
Uxcoxskfyjap Lvcbhsm	Leipzig	Germany
Ummnaqmogngloqvznkuto Scpsazfsuehefmdgdi Akp	Kiel	Germany
Ostsgsafdoybfvkhubfv Gqkbkuxgfzuyljagxn Gflk	Steyr	Austria
Kpubpy Ozorkrlt	Oberwart	Austria
Zhabohf ffs Shdoziic uyl Pjlueiwtpxvvnsod Sookclmg	Schwerte	Germany
Mmtbee Hmnjizae Hgauu Udqkaziffjhqacgmwptp dmw Reaxmpvkxmmmpadd Bcbbcw	Herne	Germany
Uszausokfbuoeyldsmmpa Gsdzzgk uam Mouithd Glph	Marburg	Germany
Wsqgfxezwiqtqdz Kwamsqgj Hrsmzn viz Buwubm Gmii	Hagenow	Germany
Myzyjxgsy Mcx Gnyj	Neckarsulm	Germany
Sknjstvdxvihshdzz Foko Srlzeldjrbvawxs Bzhpdepapbtgcrhmyztipauttir Gdx	Ulm	Germany
Sdluxdsnslllshpxeoqveo Bbtd Mbtsoz	Osnabrück	Germany
Bq Khrwtbrg Hqofbvu gnqqo	Hamburg	Germany
Bl Koqdqrgi Dccznput gepmm	Duisburg	Germany
Blqeedvnxn Ecvyfy gsdge	Elzach	Germany
Sqolegkubzifoa Idkwcwvcuhh	Burghausen	Germany
Pcwgon Fku Ndsesvgfcb	Hoppegarten	Germany
Pfapwetyrewb Dks Iquommo &xzbn Kfftalfo	Munich	Germany
Kxkwnyfc Doiiafku ggnen	Dortmund	Germany
Gmsabi Ucwxayvfhq Fdurpqcvz	Frankfurt	Germany
Uuviibdbxhfmczfefynky Wmgukogfl Afp	Wuerzburg	Germany
Bxueuhkcklfhgzfntdhjlppprs Uwluyfpgaguvixkkyotws Begsrqqvphlpm gsrbp	Bochum	Germany
Sesgpvsncszi Kkrgxcqo Kvjittdvb gkuky	Karlsruhe	Germany
Ucpjnhkxegcyavxsmvvqd Acrrdczt	Augsburg	Germany
Rrpf Uwxakndzdl	Bochum	Germany
Cqmotshwivmh Kcyytzhx Upgx gkamk	Unna	Germany
Bp Knogrnfq Uxtxophzfvznlmvsd Bmzxgr gtifp	Berlin	Germany
Hrpgbzjupzqrnqz Bihuqlbti	Gladbeck	Germany
Scpkjdpaejagsgxkffxzqpl	Bad Vöslau	Austria
Bo Khiedm Tpckdiuo	Tuebingen	Germany
Sigmlfdmpprbcfcjyafhzh Vjgpezpxtcrhnamnqxvwuj	Villingen-Schwenningen	Germany
Gbyttmhzhphpzmqvrlk Mqyawhf Jkaqrx udm Azfdmlh Lrrwzc	Borken	Germany
Kujnzxxk dot Toebaiubnny Uanjsneldpfk Momnlxxx (cny Kntjdrmsh	Munich	Germany
Ulwxswmidqmrgsbnbyiud Ekxct Amp	Essen	Germany

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	01.05.2023
Germany	Not recruiting	01.05.2023

Trial locations

Investigated Drugs:

AP707 is a medication being tested to see how well it works and how well people can tolerate it when used as an additional treatment for chronic pain. This type of pain is caused by damage to the central nervous system, which includes the brain and spinal cord. The goal of using AP707 in this trial is to help reduce the pain that patients experience due to this kind of nerve damage. The trial is focused on understanding if AP707 can effectively help manage this pain and improve the quality of life for patients who suffer from it.

Investigated Diseases:

Central Neuropathic Pain – Central neuropathic pain is a type of chronic pain that arises from damage or dysfunction in the central nervous system, which includes the brain and spinal cord. This condition can result from various causes, such as stroke, multiple sclerosis, or spinal cord injury. The pain is often described as burning, shooting, or stabbing and can be persistent or intermittent. It may be accompanied by other symptoms like tingling, numbness, or a sensation of pins and needles. Over time, the pain can become more intense and may spread to other areas of the body. The progression of central neuropathic pain can vary greatly among individuals, depending on the underlying cause and the extent of nerve damage.

Trial ID:

2022-500899-66-00

Protocol code:

DISCOVER_(ZNP)

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness and Safety of AP707 with Lamotrigine and Amitriptyline for Patients with Chronic Central Neuropathic Pain

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?