A study testing the safety and effectiveness of BP1.

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What is this study about?

This study is looking at obsessive compulsive disorder, which is a mental health condition where people experience unwanted repetitive thoughts and feel compelled to perform certain behaviors over and over again. The study will test a medication called BP1.4979, which is being given as a tablet taken by mouth. Some participants will receive BP1.4979 while others will receive placebo. The main goal is to find out if BP1.4979 is safe and can help reduce the symptoms of obsessive compulsive disorder in adults who have not improved enough with their current treatment.

Participants in this study will already be taking other medications for their condition but will continue on stable doses of these medicines throughout the study. The study medication or placebo will be taken daily for 12 weeks. The study is designed so that neither the participants nor the doctors will know who is receiving the actual medication and who is receiving placebo during the treatment period. The maximum daily amount of BP1.4979 that can be given is 40 milligrams.

During the study, participants will have several visits where doctors will assess how severe their obsessive compulsive symptoms are using questionnaires and rating scales. These assessments will measure things like the frequency and intensity of unwanted thoughts and repetitive behaviors, overall functioning, and mood. The doctors will also monitor for any side effects or problems that might occur during treatment. The study will help determine whether this new medication could be a useful option for treating people with moderate to severe obsessive compulsive disorder who have not responded well enough to existing treatments.

1 Initial treatment period begins

Your participation in the clinical trial starts after the initial procedures have been completed.

You will be randomly assigned to receive either BP1.4979 or a placebo. A placebo is an inactive substance that looks like the actual medication but contains no active drug.

The medication is provided as a tablet that you will take by mouth.

The active substance in BP1.4979 is n-[4-[2-[4-(3-cyanophenyl)piperazin-1-yl]ethyl]cyclohexyl]-3-methoxypropanamide.

Neither you nor your doctor will know which treatment you are receiving during the trial. This is called a double-blind study.

2 Continuation of stable medication regimen

You will continue taking any psychiatric medications you were already using before joining the trial.

These medications must remain at the same dose throughout your participation in the study.

Your doses should have been stable for at least 8 weeks before screening and at least 12 weeks before starting the trial medication.

3 Regular assessment visits during treatment

You will attend multiple visits during the treatment period.

At Visit 3, your symptoms will be assessed using the Yale-Brown Obsessive-Compulsive Scale Second Edition, which measures the severity of obsessive-compulsive disorder symptoms.

At Visit 4, the same assessment will be repeated.

During these visits, you will also complete the Obsessive-Compulsive Inventory-Revised, a questionnaire that evaluates various aspects of obsessive-compulsive symptoms.

Your overall functioning will be evaluated using the Clinical Global Impressions scale, which assesses changes in your condition.

Depression symptoms will be measured using the Montgomery and Asberg Depression rating scale.

4 End of treatment assessment

At Visit 5, which marks the end of the treatment period, a final comprehensive assessment will be conducted.

The primary measurement will be the change in your Yale-Brown Obsessive-Compulsive Scale Second Edition total score compared to the beginning of treatment.

You will complete the Obsessive-Compulsive Inventory-Revised questionnaire again.

Additional assessments of your overall functioning and depression symptoms will be performed.

The safety and tolerability of the medication will be evaluated throughout the trial.

5 Follow-up period

After completing the treatment period, you will enter a follow-up phase.

If you are a woman of childbearing potential, you must continue using effective contraception for one month after stopping the trial medication.

The trial is expected to continue until February 2028.

Who Can Join the Study?

You must provide written informed consent, which means you agree in writing to take part in the trial before any trial procedures begin.
You must be between 18 and 75 years old, male or female.
You must have a main diagnosis of OCD, which stands for obsessive compulsive disorder, for at least 1 year. You may or may not have had or currently have tics, which are sudden, repetitive movements or sounds. You must have good or fair insight, meaning you recognize that your obsessions or compulsions are excessive or unreasonable.
You must have moderate to severe OCD, shown by a score of at least 22 points on a specific rating scale called YBOCS-II, which measures the severity of your symptoms. This score must be checked at two visits, and the score should not improve or worsen by more than 35% between these visits.
You must be currently receiving medication treatment for OCD at an appropriate dose and for an appropriate length of time, but the treatment has only helped partially or has not provided enough improvement in your symptoms.
If you are taking other psychiatric medications, which are medicines for mental health conditions, you must have been on stable doses for at least 8 weeks before the first visit and at least 12 weeks before the second visit when treatment starts.
You must have a cooperative attitude and be able to understand and follow all trial requirements and procedures, such as completing questionnaires, taking the medication as directed, and not using medications that are not allowed during the trial.
If you are a female participant, you must either be post-menopausal, which means you have not had a menstrual period for at least 12 months naturally, or you must be a woman of childbearing potential using a highly effective method of contraception, which is birth control, during the trial and for one month after stopping the trial medication. Women who have had surgery to remove their uterus, fallopian tubes, or ovaries are also eligible.
If required by your country, you must be covered by appropriate national health insurance.

Who Cannot Join the Study?

No specific exclusion criteria have been provided for this clinical trial at this time.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain
Clinic BBP Bozena Pawelczyk	Katowice	Poland
Hospital Universitario De Salamanca	Salamanca	Spain
Centro Hospitalar Universitario Sao Joao E.P.E.	Porto	Portugal
Gyncentrum Sp. z o.o.	Katowice	Poland

Other Sites

Site Name	City	Country
Azienda Sanitaria Universitaria Friuli Centrale	Udine	Italy
Hospital Beatriz Angelo	Loures	Portugal
CCAB Centro Clinico Academico Braga Associacao	Braga	Portugal
Centro Di Neurologia Psichiatria E Psicologia Clinica S.r.l.	Florence	Italy
Centrum Psychiatrii W Katowicach Im. Dr. Krzysztofa Czumy	Katowice	Poland
Virgen del Rocío University Hospital	Sevilla	Spain
Ospedale San Raffaele S.r.l.	Milan	Italy
Champalimaud Clinical Centre	Lisbon	Portugal
Hospital Alvaro Cunqueiro	Vigo	Spain
Gyncentrum Sp. z o.o.	Warsaw	Poland
Cfsxqxg Bvmtv Kwjqavfmdpb Pochtjyn Spi z oeiu	Gdansk	Poland
Gbamvaxduz Rvygfzwi Sal z owvt	Wroclaw	Poland
Hlqgfcjt Vuvr dzajbnxb	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	01.01.2026
Poland	Recruiting	01.01.2026
Portugal	Recruiting	01.01.2026
Spain	Recruiting	01.01.2026

Trial locations

Investigated drugs:

N-[4-[2-[4-(3-Cyanophenyl)Piperazin-1-Yl]Ethyl]Cyclohexyl]-3-Methoxypropanamide

BP1.4979 is an investigational medication being tested in this clinical trial for the treatment of obsessive compulsive disorder (OCD). This is an experimental drug that is being studied to see if it can help reduce the symptoms of OCD in adults. The trial will examine how well BP1.4979 works and whether it is safe for people with this condition to use.

Placebo is an inactive substance that looks like the real medication but contains no active treatment. It is used in the study to compare against BP1.4979 to help determine if the actual medication is effective. Some participants will receive the placebo instead of the active medication, but neither the participants nor the doctors will know who is receiving which treatment during the study.

Investigated diseases:

Obsessive-compulsive disorder

Obsessive Compulsive Disorder – Obsessive compulsive disorder is a mental health condition characterized by unwanted, recurring thoughts called obsessions and repetitive behaviors or mental acts called compulsions. People with this disorder feel driven to perform these compulsive behaviors in response to their obsessive thoughts, often to reduce anxiety or prevent something bad from happening. The obsessions can involve fears about contamination, harm, or needing things to be in a particular order or symmetrical. Compulsions may include excessive cleaning, checking, counting, or arranging items repeatedly. These symptoms consume significant time and interfere with daily activities, work, and relationships. The disorder typically follows a chronic course with symptoms that may vary in intensity over time.

Trial ID:

2025-522026-13-00

Protocol code:

P24-05

Trial Phase:

Therapeutic exploratory (Phase II)

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A study testing the safety and effectiveness of BP1.

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