In short
Clinical trials are studying Amantadine Hydrochloride in people with advanced Parkinson’s disease and multiple sclerosis. These studies look at whether it helps with motor fluctuations and fatigue, and they measure outcomes such as symptom change and treatment effect over time.
Key points
- Clinical trials of Amantadine Hydrochloride are studying two main problems: motor fluctuations in advanced Parkinson’s disease and fatigue in multiple sclerosis. One study is a Phase 2 trial in 132 people with advanced Parkinson’s disease, and the other is a Phase 3 trial in 144 people with multiple sclerosis. The Parkinson’s study measures Off-time using Hauser diaries over 3 months. The multiple sclerosis study measures fatigue using the MFIS questionnaire over 6 weeks. Both studies are interventional and are listed as Authorised.
Trial overview
Two interventional clinical trials are studying Amantadine Hydrochloride in different patient groups. One trial looks at advanced Parkinson’s disease, and the other looks at multiple sclerosis (MS).
Both studies are listed as Authorised, which means they have approval to run. The trials are designed to see whether the study treatment improves symptoms compared with a comparison treatment or placebo.
Advanced Parkinson’s disease study
The Parkinson’s disease trial is titled as a randomized, double-blinded, placebo-controlled study of Amantadine Hydrochloride as add-on therapy for motor fluctuations in advanced Parkinson’s disease. It is a Phase 2 study with 132 participants.
The main goal is to evaluate whether Amantadine Hydrochloride helps reduce motor fluctuations, especially Off-time, after 3 months of treatment. Off-time means periods when movement symptoms get worse again during the day.
The study compares Amantadine Hydrochloride with placebo, which is a treatment without active study drug used for comparison. The main outcome is the change from the start of the study to the end point at 3 months, measured with Hauser diaries filled in over 3 consecutive days.
Multiple sclerosis study
The multiple sclerosis trial is a Phase 3 controlled, randomised, double-blind, crossover study in 144 participants. It studies Amantadine Hydrochloride for fatigue in people with MS.
This study compares Amantadine Hydrochloride alone, and also in combination with transcranial magnetic stimulation, against placebo for fatigue treatment. A crossover trial means participants may receive more than one study treatment during different study periods.
The main outcome is the change in the MFIS questionnaire score, which is used to measure fatigue in MS. The brief summary says the effect is assessed at 6 weeks.
Study design and measures
Both trials are interventional studies, meaning researchers actively give a treatment and then measure the results. Both also use comparison groups, which helps show whether the study treatment works better than placebo or another approach.
The Parkinson’s study uses a double-blinded design, so the people in the study and the study team do not know who gets which treatment during the trial. The MS study is also randomised and double-blind, which helps reduce bias in the results.
The main outcomes are symptom-based measures rather than laboratory tests. In Parkinson’s disease, the focus is on movement problems and Off-time, while in MS the focus is on fatigue.
Who the trials are for
The target population for one study is people with advanced Parkinson’s disease. The target population for the other is people with multiple sclerosis (MS).
These trial records do not give full entry rules, so the main information available is the condition being studied and the number of participants planned. The planned enrollment is 132 for the Parkinson’s study and 144 for the MS study.
What the trials are trying to show
These studies are trying to find out whether Amantadine Hydrochloride improves symptoms in the groups being studied. For Parkinson’s disease, the key question is whether it reduces motor fluctuations and Off-time over 3 months.
For multiple sclerosis, the key question is whether it lowers fatigue scores on the MFIS questionnaire over 6 weeks. Together, these trials focus on whether the treatment can help with real-life symptoms that matter to patients.