Table of contents
- Trial overview
- Advanced Parkinson’s disease study
- Multiple sclerosis study
- Study design and measures
- Who the trials are for
- What the trials are trying to show
Trial overview
Two interventional clinical trials are studying Amantadine Hydrochloride in different patient groups.[1][2] One trial looks at advanced Parkinson’s disease, and the other looks at multiple sclerosis (MS).[1][2]
Both studies are listed as Authorised, which means they have approval to run.[1][2] The trials are designed to see whether the study treatment improves symptoms compared with a comparison treatment or placebo.[1][2]
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.[1] It is a Phase 2 study with 132 participants.[1]
The main goal is to evaluate whether Amantadine Hydrochloride helps reduce motor fluctuations, especially Off-time, after 3 months of treatment.[1] Off-time means periods when movement symptoms get worse again during the day.[1]
The study compares Amantadine Hydrochloride with placebo, which is a treatment without active study drug used for comparison.[1] 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.[1]
Multiple sclerosis study
The multiple sclerosis trial is a Phase 3 controlled, randomised, double-blind, crossover study in 144 participants.[2] It studies Amantadine Hydrochloride for fatigue in people with MS.[2]
This study compares Amantadine Hydrochloride alone, and also in combination with transcranial magnetic stimulation, against placebo for fatigue treatment.[2] A crossover trial means participants may receive more than one study treatment during different study periods.[2]
The main outcome is the change in the MFIS questionnaire score, which is used to measure fatigue in MS.[2] The brief summary says the effect is assessed at 6 weeks.[2]
Study design and measures
Both trials are interventional studies, meaning researchers actively give a treatment and then measure the results.[1][2] Both also use comparison groups, which helps show whether the study treatment works better than placebo or another approach.[1][2]
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.[1] The MS study is also randomised and double-blind, which helps reduce bias in the results.[2]
The main outcomes are symptom-based measures rather than laboratory tests.[1][2] In Parkinson’s disease, the focus is on movement problems and Off-time, while in MS the focus is on fatigue.[1][2]
Who the trials are for
The target population for one study is people with advanced Parkinson’s disease.[1] The target population for the other is people with multiple sclerosis (MS).[2]
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.[1][2] The planned enrollment is 132 for the Parkinson’s study and 144 for the MS study.[1][2]
What the trials are trying to show
These studies are trying to find out whether Amantadine Hydrochloride improves symptoms in the groups being studied.[1][2] For Parkinson’s disease, the key question is whether it reduces motor fluctuations and Off-time over 3 months.[1]
For multiple sclerosis, the key question is whether it lowers fatigue scores on the MFIS questionnaire over 6 weeks.[2] Together, these trials focus on whether the treatment can help with real-life symptoms that matter to patients.[1][2]
