News

Fampridine Trial

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Whilst the Fampridine trial has finished recruiting Associate Professor of Neuroscience, Arun Krishnan PhD FRACP and his team are undertaking follow-up of the final group of patients. The Institute expects to have results available towards the end of this year.

Irrespective of the trial, Assoc. Prof. Krishnan is always interested in seeing new CIDP patients who would like to be involved in research.

He undertakes studies in numerous different types of neuropathy, including CIDP. He and the team are focused on developing new ways of monitoring treatment response in CIDP as well as enabling new insights into the cause of neuropathic symptoms in this patient group.

His work is conducted at the University of New South Wales and as a consultant neurologist at Prince of Wales Hospital. The group's main area of research interest is in developing new ways to diagnose and treat peripheral neuropathy. From a clinical perspective, he manages the Nerve and Muscle Service at Prince of Wales Hospital which provides highly specialised care for the diagnosis and treatment of patients with neuropathy. The clinic can be contacted on 93822413 or 93823912. Additionally, the Nerve and Muscle Clinic at Prince of Wales Hospital may also be a useful resource for some patients.


 

CLOSED Clinical Trial

Does Fampridine improve fatigue in patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)?

Description of intervention(s) / exposure: The purpose is to investigate whether treatment with the medication, Fampridine, can help improve the ability to function in patients who have chronic inflammatory demyelinating polyneuropathy (CIDP).

Who is this for? You are eligible to participate in this study if you are ages between 18-80, have CIDP and currently suffer from fatigue and a decreased functional ability. In this study with patients will receiving 12 weeks of Fampridine (active drug) at a dose of 10mg oral tablet twice daily, and 12 weeks of placebo (sham) treatment consisting of lactose tablets, separated by a 4-week washout period.

During the trial, participants will not know if they are receiving active drug or the placebo. Participants will be assessed at baseline followed by 4 weekly intervals to measure fatigue, functional ability and nerve function.

Fampridine- PR: Oral tablet, 10mg twice daily for a period of 12 weeks. The study is a double-blind placebo-controlled crossover study, with patients receiving 12 weeks of active drug and 12 weeks of placebo, separated by a 4-week washout period.

Control treatment: Placebo Glucose tablet identical in taste and appearance to the active drug.

Key inclusion criteria:

Definitive diagnosis of CIDP: 18-80 years of age;; Able to provide informed consent.

Minimum Age: 18 Years

Maximum Age: 80 Years

Gender: Both males and females

Healthy volunteers: No

Key exclusion criteria:

  • History of seizures. Current treatment with anticonvulsant medication
  • Pregnancy or lactation. Contraception is required in pre-menopausal female patients
  • History of moderate-severe renal impairment
  • Presence of serious psychiatric disorder (e.g major depression, bipolar disorder) Enrolled in another clinical trial involving an investigational agent
  • Known allergy to pyridine-containing substances
  • History of renal dysfunction

Primary outcome: Six-minute walk test: validated measure that has been used to assess functional capacity in neuromuscular disease. In this setting, it is viewed as a measure of activity-dependent fatigue in patients with demyelinating disease. (ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories 2002;; Kierkegaard & Tollback 2007;; McDonald et al 2010). (Goldman et al 2008)

Secondary outcome 1: Peripheral nerve excitability measurement

Secondary outcome 2: Handgrip dynamometry

Secondary outcome 3: Timed 25-foot walk test to assess speed by the time taken

Secondary outcome 4: Nine-hole pegboard test: to assess the time taken to complete a dexterity task

Secondary outcome 5: MRC sum score, assessed as total score and separately for upper and lower limb muscle groups.

Secondary outcome 6: Fatigue, assessed using the validated fatigue severity scale (Krupp et al 1989)