Thalidomide

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xsparklingwinex

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Does anyone know why the FDA terminated the clinical trial for Thalidomide? :confused:
 

Ran

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Hi, I don't have an answer for your question but I find this somewhere:
a Simple Facts Sheet from the AIDS Treatment Data Network
[pill]thalidomide

Thalidomide was banned in the early 1960s after it was found to cause deformed limbs in the children of women who took it early in pregnancy. The drug is now being investigated for use in treating AIDS, tuberculosis, and other illnesses.

Researchers have found that thalidomide can inhibit the growth of HIV in test tubes. Thalidomide works in lab experiments against HIV by suppressing a natural substance produced in the body. The substance is called tumor necrosis factor (TNF), also known as cachectin. TNF is released by white cells during infection and helps fight invading organisms.

In some people with HIV infection, the production of TNF is high. High TNF levels are associated with more rapid progression to AIDS and with the development of HIV related central nervous system disease. Excessive production of TNF over a period of time may lead to weight loss and/or interfere with the ability of the immune system to deal with infections.

In a small trial, treatment with thalidomide was found to help with severe weight loss in people with AIDS. Researchers concluded that thalidomide had a beneficial effect on the symptoms of wasting syndrome but did not improve T4 cell counts or reduce HIV replication in this study.

Trials have also shown that thalidomide can treat mouth ulcers very effectively in people with HIV. The technical name for this condition is aphthous ulcers. Other studies for HIV and related conditions are ongoing.

Side effects of thalidomide include: sleepiness, drowsiness, constipation, skin rash, severe headaches, stomach aches, peripheral neuropathy (numbness and pain in your arms, hands, legs and feet) dizziness and nausea, giddiness or nervousness at higher doses, shivering and buzzing in the ears, depression or mood-swings, a general sense of illness and severe birth defects if taken even once during pregnancy.

The drug company that makes thalidomide is Celgene. Their brand is called Thalidomid. Thalidomid is now approved for the treatment of a condition associated with leprosy. For more information Celgene can be reached at (800) 890-4619 x3905.

Thalidomide, which was developed in the 1950s to prevent nausea during pregnancy but was found to produce fetal limb abnormalities, has been found to inhibit replication of the AIDS virus and to heal canker sores in patients with AIDS and other conditions. Thalidomide is used for treatment some symptoms of Hansen's disease, or leprosy.


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xsparklingwinex

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Thank you.. I also ended up finding this.. : Clinical Trial of Thalidomide
Dartmouth-Hitchcock Medical Center

Background:

Previous research has shown that an immune-system compound called TNF-alpha is elevated in ALS. There is evidence that thalidomide may reduce the synthesis of this substance. The proposed study is designed to determine the response to thalidomide in patients with ALS.

STUDY DETAILS:

All participants were seen at Dartmouth-Hitchcock Medical Center in Lebanon, N.H. Patients are seen every treatment "cycle," and each cycle is 90 days. They will be treated for three cycles, at which time the main outcome measure will be evaluated. Participants will take thalidomide for nine months and all participants will receive the drug.

The main outcome used to evaluate results will be the participant's score on the ALSFRS and pulmonary function test results.

The secondary outcomes measured will be drug toxicity, quality of life, any changes in cytokine levels, and survival time, adjusted for newly diagnosed and later stages of the disease.
 

xsparklingwinex

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Why the study was terminated:

OBJECTIVE : Neuroinflammation contributes to motor neuron degeneration in ALS. Thalidomide (THL) shows potent anti-inflammatory properties and increased the lifespan in ALS transgenic mice. Thalidomide was therefore suggested as atherapeutic intervention for the treatment of ALS.We conducted a pilot, randomized clinical trial of THL in patients with ALS to assess safety, feasibility, and preliminary estimates of treatment efficacy. METHODS : Patients were randomized to THL in combination with riluzole (n = 18) or riluzole alone (n = 19). THL was initiated at 100 mg per day for 6 weeks. Thereafter, the dose was increased every week by 50 mg until reaching the dose of 400 mg per day and planned to continue for another 12 weeks. RESULTS : Within 12 weeks of THL treatment, nine THL patients (50%) developed bradycardia defined as a heart rate below 60 beats per minute (bpm) and ranged from 46 to 59 bpm. Mean heart rate dropped by 17 bpm with THL treatment. Severe symptomatic bradycardia of 30 bpm occurred in one patient. A further patient died from sudden unexpected death. The study was terminated prematurely for safety concerns. The secondary outcome variables showed similar results for both groups. CONCLUSION : Bradycardia was the most common adverse event of THL treatment in ALS. THL-related bradycardia does not appear to be ALS-specific. It is conceivable, however, that the unexpected frequency and severity of THL-induced bradycardia may be related to subclinical involvement of the autonomic nervous system in ALS. The cardiac toxicity discourages further clinical trials and compassionate use of THL in ALS. ClinicalTrials.gov Identifier: NCT00231140.

Thalidomide causes sinus bradycardia in ALS. [J Neurol. 2008] - PubMed result
 
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