CLINICAL TRIALS
Figure 9: CNS trials initiated in the past 12 months by disease
35
30
By Dr Christine Blazynski, vice-president operations at Citeline
In the CNS therapeutic area, a total of 354 industry-sponsored
25 Phase III
Phase II to Phase III trials were initiated between September 1st,
2007, and August 31st, 2008. Among these, the largest number
of overall trial starts involved trials for pain symptoms
ts 20 Phase II/III
(neuropathic and nociceptive; 19%), followed closely by
schizophrenia (17%), Alzheimer’s disease and depression. Of
the 185 Phase II clinical trials started in the same 12-month
T
rial star 15
Phase II
period, the largest number focusued on pain (neuropathic and
nociceptive), followed by schizophrenia. Among Phase III trial
starts, epilepsy had the largest number, and a significant
10
number of these are likely to be registration trials. If trials
focused on both neuropathic and nociceptive pain are
combined, a total of 24 trials were initiated. Depression follows
5
closely. Epilepsy and bipolar disorder are notable in that nearly
80% of the industry-sponsored trials initiated in the last 12
months were Phase III trials; for depression, nearly 60% of the
0
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starts were Phase III studies.
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Insomnia Migraine
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Source: TrialTrove; accessed September 16th, 2008
Figure 10: CNS trials initiated in the past 12 months by company (top 20; Phases II-III)
35
30
Phase III
Among the companies with at least 10 trial starts in the past
12 months, Pfizer is the clear leader, with a total of 31 starts, of
which 16 are Phase III. Nearly one-third (6) of Pfizer’s Phase III
Phase II/III
trials are for epilepsy, followed by four trials each for
25
neuropathic pain and anxiety. Pfizer continues to seek approval
for gabapentin and pregabalin beyond the US. Four trials with
Phase II
Pfizer’s calcium channel opener, PD-0332334, were also
initiated in the past 12 months. GlaxoSmithKline follows Pfizer
ts
20
with 50% fewer trial starts; of these the highest activity is seen
for Alzheimer’s disease and for bipolar disorder. Three of four
trials in Alzheimer’s are investigating efficacy of an extended-
T
rial star
15 release version of rosiglitazone, and for bipolar disorder, four
trials involve lamotrigine in either specialised patient
populations or are being run in Japan. Rounding out the top
four companies are Johnson & Johnson, with four of 13 trials
10
for epilepsy, and UCB with all recently inititated trials focused
on epilepsy.
5
0
y
tis
Pf_izer
UCB
Lill
eda
ohnson
v
entis Eisai
var
y
eth
ak
Lundbeck
Abbott
ck & Co
W T
Anesiva
Lundbeck
No Sepracor
AstraZeneca Mer
Sanof_i-A eda;
GlaxoSmithKline
J
ohnson & J
T
ak
Schering-Plough
Boehringer Ingelheim
Otsuka Pharmaceutical
Source: TrialTrove; accessed September 16th, 2008
84
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